Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

Официальное название

Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study

Обзор

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Вмешательства

• Препарат blinatumomab
  The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: 2 years]
• 100 day adverse events (AE) [Срок оценки: Day +100]

Вторичные конечные точки (5)

• Non-relapse mortality (NRM) [Срок оценки: 6 months]
• Relapse rate [Срок оценки: 2 years]
• Overall survival (OS) [Срок оценки: 2 years]
• Cumulative incidence of acute graft versus host disease (aGVHD) [Срок оценки: Day +100]
• Cumulative incidence of chronic graft versus host disease (cGVHD) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
• Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
• KPS > 60 or ECOG 0-2;
• The expected survival time is more than 3 months;
• Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
• Reach the standard of hematopoietic reconstitution (neutrophil count

≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation;

• No central nervous system involvement or clinical symptoms after transplantation;
• Those who have no serious functional damage to important organs of the body;
• Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
• Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

Критерии исключения

• Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
• Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
• Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
• Poor graft function (PGF) occurred after allo-HSCT;
• Combined with other malignant tumors and require treatment;
• Active GVHD;
• Have a history of allergy to Chidamide;
• Pregnant or lactating females;
• Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
• Patients with active chronic hepatitis B or active hepatitis C;
• History of prolonged QT syndrome;
• Patients considered by other researchers to be unsuitable for this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT06075238 · PT-Blin 1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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